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efanesoctocog alfa (BIVV001) for Hemophilia A (XTEND-Kids Trial)
XTEND-Kids Trial Summary
This trial is testing a new medication, BIVV001, for safety in children with hemophilia A who have been treated before. They will also look at how well it works as a preventative treatment and for treating bleeding episodes, how much of the medication is needed, and any side effects.
XTEND-Kids Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowXTEND-Kids Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 159 Patients • NCT04161495XTEND-Kids Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
What are the precedents for this research?
"Bioverativ, a subsidiary of Sanofi, first began to study efanesoctocog alfa (BIVV001) in 2021. After the initial trial with 75 participants in that same year, Phase 3 drug approval was given. As of now, there are three active studies being conducted for efanesoctocog alfa (BIVV001), located in 41 different cities and 23 countries around the world."
Are there any observed side effects of efanesoctocog alfa (BIVV001)?
"There is a significant body of evidence both for and against the efficacy of efanesoctocog alfa (BIVV001), so it received a score of 3."
What are the results of efanesoctocog alfa (BIVV001) clinical trials thus far?
"In 2021, efanesoctocog alfa (BIVV001) was first trialled at Investigational Site Number: 0560001. Since then, there have been 3 completed studies with many more ongoing clinical trials, some of which are based in Greenville, North carolina."
How many different sites are participating in this research?
"There are 26 different hospitals and clinics running this clinical trial at the moment. They are located in Greenville, Ottawa and Pittsburgh as well as 23 other places. If you want to minimize your travel requirements, try and select a location that is close to you."
How many individuals are under observation in this clinical trial?
"Although this study was posted on February 19th, 2021 and updated recently on May 10th, 2022, it is not currently recruiting patients. If you are interested in participating in other clinical trials, there are 91 studies searching for patients with hemophilia a and 3 efanesoctocog alfa (BIVV001) studies that still need participants."
Are new participants being enrolled in this clinical trial at this time?
"Unfortunately, this clinical trial is not looking for any more participants at the moment. The original posting was on February 19th, 2021 and there have been edits as recently as May 10th, 2022. However, if you are seeking other studies, 91 trials for patients with hemophilia A and 3 trials for efanesoctocog alfa (BIVV001) are currently admitting new members."
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